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Antenatal Allopurinol in Intrauterine Growth Restriction

NCT ID: NCT00346463

Last Updated: 2008-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2013-07-31

Brief Summary

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Growth retardation in utero may be caused by uteroplacental vascular insufficiency. When Doppler ultrasound studies of the umbilical artery are abnormal pathological intrauterine growth restriction (IUGR) can be diagnosed. IUGR fetuses have a higher mortality and morbidity, both perinatally and on the longer term. This is probably due to chronic malnourishment and hypoxia due to placental insufficiency. This placental dysfunction causes generation of harmful free oxygen radicals in the fetus. The IUGR fetus has a diminished antioxidative capacity which means these free radicals cannot be buffered sufficiently. This leads to fetal oxidative stress.

Previous studies have shown that allopurinol can inhibit the cascades that lead to generation of free radicals. High dosed allopurinol also scavenges radicals and binds free iron without adverse effects on the fetus or mother.

As IUGR is associated with placental insufficiency and excessive production of free radicals we hypothesize that antenatal allopurinol administration could lead to a decrease in oxidative stress in the mother and fetus and subsequent improvement of the maternal and/or neonatal outcome.

Detailed Description

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Conditions

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Fetal Growth Retardation

Keywords

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Allopurinol Fetal Growth Retardation Oxidative Stress Placental Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Allopurinol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Mothers with a gestational age (GA) of 30 to 36 weeks with:

* Foetal growth retardation (growth \<10th percentile) and
* Abnormal Doppler flow in the umbilical cord (umbilical artery pulsatility index (PI)\>95th percentile)

Exclusion Criteria

* Congenital, chromosomal or syndromal abnormalities
* Positive screening for intrauterine viral infections
* Mothers with gout and high uric acid
* creatinine \> 100 umol/l
* ASAT \> 80 U/l, ALAT \> 80 U/l
* Uric acid \> 0,50 mmol/l
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Principal Investigators

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Frank van Bel, Prof MD, PhD

Role: STUDY_DIRECTOR

Wilhelmina Children's Hospital / UMC Utrecht

Manon Benders, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wilhelmina Children's Hospital, UMC Utrecht

Helen Torrance, MD

Role: PRINCIPAL_INVESTIGATOR

Wilhelmina Children's Hospital / UMC Utrecht

Locations

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Wilhelmina Children's Hospital / UMC Utrecht

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Manon Benders, MD, PhD

Role: CONTACT

Phone: 0031 30 2504545

Email: [email protected]

Frank van Bel, Prof MD, PhD

Role: CONTACT

Phone: 0031 30 2504545

Email: [email protected]

Other Identifiers

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METC UMCU 05-207K

Identifier Type: -

Identifier Source: org_study_id